Sr. Manager, Clinical Supply Chain Management & Operational Excellence

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

The Sr. Manager, Clinical Supply Chain Management & Operational Excellence is responsible for supporting SCM operational excellence projects to streamline SOPs and make processes more efficient. This individual will also support end-to-end clinical supply chain management activities which include: coordinating investigational medicinal product (IMP) planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies. This position reports to the Director, Supply Chain Management.

Responsibilities

• Leads continuous improvement projects to optimize processes by analyzing KPI, and fostering cross functional collaborations for improvements
• Develop and manage SOPs, work instructions, processes, systems, and forms governing supply chain management, including international logistics, in alignment with industry standards and regulatory requirements
• Support projects and process improvement efforts related to supply chain management, both clinical and commercial
• Support budget activities, including managing proposals, contracts, PO generation and invoicing approvals for clinical packaging/distribution/storage
• Strengthen oversight and tracking of Trial Master File (TMF) documents, ensuring timely, accurate, and inspection-ready documentation for all clinical supply activities.
• Work with external courier and depot vendors to set up storage, Import & Export, distribution, drug return, and destruction according to the Logistics SOP/Global Standards (GDP) and related logistics procedures
• Facilitates and coordinates with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including pre-conditioned shipping containers/materials, temperature data loggers, pick-up appointments, and expedited order and emergency delivery situations
• Leads and oversees the execution of temperature-controlled, on-time distribution of Eidos drug supply chain, ensuring on-time delivery and manage temperature excursions as needed
• Coordinate with external bureaus, including Customs, FDA, USDA, and/or other applicable country agencies, to resolve logistics issues in a timely manner
• Ensures the requirements and business processes associated with cross-border movements function smoothly, issues and risks are identified and managed efficiently
• Importer Of Record setup and management as applicable globally and supports import permit applications and corresponding import VAT refund as needed
• Works with internal departments including QA, Finance, Tax, procurement, Legal, and RA to resolve logistics issues, as required
• Collaborate with Clinical Operations and internal stakeholders to align on clinical demand requirements and ensure labeling and distribution plans remain adaptive to program timelines, study design changes, recruitment needs, geographic considerations, and manufacturing schedules. Act as CMC/Supply Chain SME for any potential audits
• Collaborate with QA counterparts to ensure inspection readiness and process control for all import/export and applicable clinical trial activities; may participate in regulatory inspections
• Manage and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management and any regulatory reporting requirements related to import and export activities
• Assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process

Where You'll Work

This is a hybrid role and requires in-office collaboration 2x per week, or as needed, in our San Francisco, CA offices.

Who You Are

• 5+ years of progressive experience in Supply Chain within the biotech/pharmaceutical industry
• A minimum of 3 years in a global forwarding/trade compliance operation role for clinical/commercial products, including import/export experience and temperature-controlled distribution protocols, manage ad hoc Customs compliance issues in a regulated pharmaceutical/biotech environment
• Bachelor’s degree in Supply Chain, Business Administration, Operations Management, or similar required
• In-depth understanding of project management processes like Lean/ Six Sigma
• Understands comprehensive global pharmaceutical regulatory requirements (e.g., cGMP, GDP, 21 CFR Part 11) and Knowledge of relevant local pharmaceutical drug product laws and regulatory guidelines
• Strong ability to collaborate and build strategic relationships with internal (Quality, Supply Planning, CMC/Manufacturing, etc.) and external (CMO, Couriers, etc.) stakeholders
• Strong understanding of import/export requirements and customs practices
• Able to independently resolve any global import & export issues, especially the logistics issues in the US/Europe
• Experience in vendor oversight and managing external partnerships and relations
• Experience in deviation investigation and CAPA implementation
• Demonstrated ability to work in a fast-paced team environment that requires quick turnaround and quality output, with minimal supervision and solid power to multi-task across competing priorities to achieve success
• Ability to foster a culture of continuous improvement and operational excellence and perform as a potential, influential leader without positional authority
• Proficient in Microsoft Office applications, IRT, and ERP systems preferred

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities